Serial locally applied water-filtered infrared a radiation in axial spondyloarthritis – a randomized controlled trial

Figures & data

Table 3. Change in functionality and disease activity between baseline and after trial completion.

		T0 (baseline)	T1 (after trial completion)	Difference	p-Value (Wilcoxon test)
BASFI	IG (n = 36)	4.1 ± 2.2	3.7 ± 2.2	−0.4 ± 0.9	p = .004
	CG (n = 35)	4.5 ± 2.6	4.1 ± 2.5	−0.4 ± 1.3	p = .055
	p-Value			p = .391
	Mann–Whitney U test
BASDAI	IG (n = 36)	4.8 ± 1.8	4.2 ± 1.8	−0.6 ± 1.1	p = .004
	CG (n = 35)	4.6 ± 2.1	4.1 ± 2.3	−0.5 ± 1.0	p = .007
	p-Value (Mann–Whitney U test)			p = .563

Functionality was measured using BASFI, disease activity was measured using BASDAI. Mean ± standard deviation and [min;max] is displayed. BASDAI is a validated tool for assessing disease activity of axSpA and contains 6 questions determining fatigue, back and joint pain, pain at the tendons and morning stiffness. The BASDAI ranges from 0 = no disease activity to 10 = maximal disease activity with a score of >4 indicating active disease. BASFI is a validated tool to determine functional restrictions due to axSpA using 10 questions related to everyday activities with a BASFI score of 0 indicating no restriction and a score of 10 indicating poorest functionality. BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functionality Index; IG: Intervention group; CG: Control group; axSpA: Axial spondyloarthritis.

Figure 1. sl-wIRAR application on the back region.

Figure 2. Trial enrollment and follow-up.

Table 1. Patient characteristics.

	Intervention group (n = 36)	Control group (n = 35)
Age (years)	51.7	51.1
Disease duration (years)	5.8	6.1
Female/male	24/12	24/11
HLA-B27 positive	n = 30	n = 32
BASDAI	4.8 ± 1.8	4.6 ± 2.1
BASFI	4.1 ± 2.2	4.5 ± 2.6
NSAID-medication	n = 34	n = 32
only non-pharmacological therapy	n = 2	n = 4

Table 2. Change in pain levels between baseline and after trial completion.

	T0 (baseline)	T1 (after trial completion)	Difference	p-Value (Wilcoxon test)
IG (n = 36)	4.1 ± 2.4 [0;8]	2.6 ± 2.0 [0;7]	−1.6 ± 1.9 [−5;2]	p < .0005
CG (n = 35)	4.8 ± 2.5 [1;9]	4.4 ± 2.2 [1;8]	−0.3 ± 1.3 [−4;3]	p = .088
p-value (Mann-Whitney U test)			p = .006

IG: Intervention group; Control group: CG.

Pain levels were measures by numeric rating scale (NRS) with 0 corresponding to no pain and 10 corresponding to maximum pain. Mean ± standard deviation and [min;max] is displayed.

Table 4. Change in TNFα levels [pg/ml] between baseline and after trial completion.

	T0 (baseline)	T1 (after trial completion)	Difference	p-Value (Wilcoxon test)
IG (n = 36)	8.8 ± 5.7	5.8 ± 4.8	−3.0 ± 4.8	p = .001
	[2.5; 19.9]	[0.1; 18.9]	[−17.5; 6.7]
CG (n = 35)	6.6 ± 3.8	6.0 ± 3.9	−0.6 ± 3.2	p = .635
	[0.3; 17.3]	[0.2; 19.9]	[−10.7; 6.7]
p-Value (Mann–Whitney U test)			p=.01

Mean ± standard deviation and [min;max] is displayed. TNFα: Tumor Necrosis Factor Alpha; IG:m Intervention group; CG: Control group.